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- **YUPELRI Record Performance**: Q3 net sales $71.4M (15% YoY), hospital share at 21%, and $25M milestone on track with $54M needed in Q4.
- **CYPRESS Trial Catalyst**: Q1 2026 readout for ampreloxetine in MSA-related nOH, with $75M Q4 milestones and $100M 2026 TRELEGY target.
- **Financial Strength**: $333M cash, non-GAAP breakeven, and clinical data supporting long-term value.
- **Strategic Focus**: Execution on CYPRESS and YUPELRI growth, with potential capital return post-data.

**【CEO Summary Section】**
- Q3 2025 highlighted strong execution across commercial and clinical fronts, with YUPELRI net sales reaching $71.4M (15% YoY growth) and breakeven on a non-GAAP basis.
- Key milestones: $25M Viatris milestone on track with $54M needed in Q4, $50M TRELEGY milestone achievable with Q4 sales of $470M, and $100M 2026 TRELEGY target within reach.
- CYPRESS Phase III trial for ampreloxetine on track for Q1 2026 readout, with $75M total Q4 milestones expected.
- Cash position of $333M with no debt, supporting near-term financial stability and long-term growth.

**【Commercial Update (YUPELRI)】**
- Q3 net sales growth driven by 6% YoY demand increase and favorable net pricing, with hospital channel volume up 29% YoY.
- YUPELRI share in long-acting nebulized hospital market at 21%, with clinical data showing reduced exacerbations vs. tiotropium.
- $25M Viatris milestone achievable with Q4 sales of $54M, underscoring brand profitability and demand trends.

**【Development Update (Ampreloxetine)】**
- CYPRESS trial progressing with open-label phase complete and randomized withdrawal phase nearing completion.
- REDWOOD subgroup data showed ampreloxetine's durable benefit in MSA-related nOH, with MCID publication supporting clinical interpretation.
- KOL event on December 8 to highlight ampreloxetine's potential as first precision therapy for MSA-related nOH.

**【Financial Performance】**
- Collaboration revenue of $20M (19% YoY growth), operating expenses of $22M (excluding share-based comp), and GAAP net income driven by one-time tax benefit.
- Non-GAAP breakeven achieved, reflecting operational efficiency and YUPELRI's profit contribution.
- TRELEGY sales of $1B in Q3, exceeding consensus and setting up $150M in expected 2025-2026 milestones.

**【Q&A Highlights】**
- Capital return decisions contingent on CYPRESS data and launch readiness, with focus on ampreloxetine execution.
- YUPELRI clinical data reinforces hospital channel growth, with new studies showing reduced health system costs.
- CYPRESS study powered to detect clinically meaningful differences, with FDA-aligned analysis plan.


Theravance Biopharma, Inc. (TBPH) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: YUPELRI net sales up 22% YoY to $66.3M, driven by demand and pricing improvements. 
- **Strategic Transactions**: $225M TRELEGY royalty sale and $7.5M China milestone boost cash to $340M. 
- **Clinical Catalyst**: CYPRESS trial nearing completion, with potential nOH/NDA approval in 2026. 
- **Financial Discipline**: Non-GAAP loss of $4.2M, $3M cash burn, and no debt. 
- **Upcoming Milestones**: $25M YUPELRI sales milestone and $150M TRELEGY milestones over next 18 months.

**【CEO Summary Section】**
- **Q2 2025 Highlights**: Strong performance with YUPELRI net sales of $66 million (22% YoY growth), $225 million TRELEGY royalty sale, and $7.5 million China approval milestone. 
- **Strategic Focus**: Advanced CYPRESS trial nearing open-label enrollment completion, with potential data readout in ~6 months. 
- **Financial Strength**: $340 million cash balance, no debt, and near cash-neutral operations. 
- **Value Drivers**: YUPELRI's durable growth, TRELEGY milestone visibility, and ampreloxetine's rare disease potential.

**【Commercial Performance (Rhonda Farnum)】**
- **YUPELRI Growth**: Q2 net sales $66.3M (22% YoY), driven by 4% demand growth, net price improvement, and specialty pharmacy pull-through. 
- **China Milestone**: $7.5M triggered by NMPA approval; Viatris leads commercialization with no Theravance costs. 
- **Hospital Channel Strength**: 31% YoY volume growth, 20% market share in long-acting nebulized asthma. 
- **2025 Sales Target**: On track for $250M threshold to trigger $25M milestone.

**【Development Update (Aine Miller)】**
- **CYPRESS Progress**: Open-label enrollment nearing completion; randomized withdrawal phase to begin soon. 
- **Design Rigor**: Replicates Study 170 MSA subgroup, with external enrollment committee and high-quality site execution. 
- **Mechanism Differentiation**: Norepinephrine reuptake inhibitor targeting preserved peripheral sympathetic function. 
- **NDA Readiness**: Modules in advanced stages; seeking priority review for potential 2026 approval.

**【Financial Results (Aziz Sawaf)】
- **Revenue Growth**: Collaboration revenue +31% YoY ($17M+ ex onetime), driven by YUPELRI margin expansion. 
- **Cost Discipline**: Non-GAAP loss $4.2M (vs $6.3M prior year), $3M cash burn (excluding onetime items). 
- **TRELEGY Milestones**: $50M due to $3.4B 2025 sales, $100M for $3.5B 2026 sales; total $150M potential. 
- **Liquidity**: $340M cash post-$225M sale; $27M tax liability accrued in Q2.

**【Q&A Highlights】**
- **YUPELRI Channel Mix**: Specialty pharmacy growth driven by persistency, but no aggressive channel shift. 
- **Ampreloxetine Pricing**: Benchmarking rare neurology drugs ($380K/year) and droxidopa ($280K/year). 
- **CYPRESS Enrollment**: Similar U.S./ex-U.S. split to Study 170; no interim data disclosure. 
- **SG&A Spend**: Stable Q3/Q4; targeted launch spend if data positive. 
- **TRELEGY Leverage**: 8% YoY sales growth, $1.1B Q2 sales vs $3.4B annual threshold.

Theravance Biopharma, Inc. (TBPH) Q2 2025 Earnings Call Transcript

- **Revenue Beat & Growth Drivers**: Q3 $12.3B (+18% YoY), cloud +25%, hardware +12%
- **AI Investment Ambition**: $10B over 3 years (40% R&D, 30% data centers)
- **Profitability Expansion**: Operating margin 16.2% (vs 15.5%), FCF $3.8B
- **2024 Outlook**: 15-18% revenue growth, >16% operating margin

**【CEO Opening Remarks】**
- Q3 revenue reached $12.3B (+18% YoY), exceeding guidance range of $11.8-12.2B.
- Key growth drivers: 25% YoY increase in cloud services, 12% growth in hardware solutions.
- Announced $10B AI infrastructure investment over next 3 years.

**【CFO Financial Highlights】**
- GAAP EPS: $1.25 (vs. $1.10 consensus)
- Non-GAAP EPS: $1.42 (+20% YoY)
- Operating margin expanded to 16.2% (15.5% last year)
- Free cash flow: $3.8B (up 12% YoY)

**【Q&A Key Themes】**
1. **AI Strategy Execution**
- Q: How will $10B investment be allocated?
- A: 40% R&D, 30% data centers, 20% partnerships, 10% talent acquisition

2. **Market Share Expansion**
- Q: North America cloud growth 25% vs. industry 18% - sustainability?
- A: 3-year contract pipeline up 35%, renewal rates >95%

3. **Profitability Outlook**
- Q: When will AI investments start contributing?
- A: 2025+; 2024 operating margin >16%

**【Closing Guidance】**
- Q4 revenue: $12.8-13.2B (+17-20% YoY)
- Full year EPS: $5.20-5.30 (prev: $5.00-5.10)
- 2024 revenue growth target: 15-18%

Theravance Biopharma (TBPH)-8 May 25-2025 Q1 Earnings call transcript

- **YUPELRI Strong Finish**: Q4 sales $66.7M (+10% YoY), hospital doses up 49% YoY, with full-year demand growth 11%.
- **TRELEGY Milestone Bonanza**: $50M received in Q1; $150M potential in 2025-2026; royalties starting 2029.
- **Ampreloxetine on Track**: CYPRESS enrollment mid-2025, top-line results Q3 2025; 90% of neurologists likely to prescribe if approved.
- **Financial Discipline**: 2024 cash burn $14M; 2025 guidance for ~$16M non-GAAP loss and similar cash burn.

**【CEO Opening Remarks】**
- Q4 2024 YUPELRI net sales reached $66.7M, up 10% YoY, with hospital doses up 49% YoY.
- Earned $50M milestone from GSK for TRELEGY 2024 sales of $3.5B.
- Ampreloxetine CYPRESS study on track for mid-2025 enrollment completion and Q3 2025 top-line results.
- Full-year 2024 cash burn of $14M, ending with $88M in cash (excluding $50M milestone receipt).

**【YUPELRI Sales Performance (Rhonda Farnum)】**
- Q4 net sales growth driven by 9% demand increase and improved channel mix (higher-margin hospital sales).
- Full-year 2024 YUPELRI sales $239M (+8% YoY), with hospital market share at ~20% and long-acting NEM share ~32%.
- Potential $25M U.S. sales milestone and China royalties post-approval.

**【TRELEGY Milestone Update (Aziz Sawaf)】**
- $50M milestone received in Q1 2025; potential $150M in 2025-2026 milestones if sales meet thresholds.
- Royalties from ex-U.S. sales starting 2029, U.S. sales 2031, with cumulative hundreds of millions expected.
- 2025 financial guidance: R&D $32-38M, SG&A $50-60M, non-GAAP loss ~$16M, cash burn similar to 2024.

**【Ampreloxetine Clinical Progress (Aine Miller)】**
- CYPRESS study enrollment on track for mid-2025 completion; 2 AAN 2025 abstracts accepted.
- FDA Type C interaction reaffirmed alignment on NDA requirements for nOH in MSA.
- Target product profile aligns with market research showing 90% of neurologists likely to prescribe if approved.

**【Q&A Highlights】**
- **Hospital Channel Success**: 14-person team focused on large systems with therapeutic interchange protocols (double market share vs. standard formulary).
- **China Regulatory Timeline**: 2-year approval window from submission; $7.5M milestone on approval, 14-20% royalties on sales.
- **FDA Feedback**: Type C meeting confirmed alignment on CYPRESS data sufficiency for NDA filing; priority review requested.
- **2025 SG&A**: Minimal FTE additions pre-CYPRESS; $55M midpoint guidance includes medical affairs and market access spend.

Theravance Biopharma (TBPH)-26 Feb 25-2024 Q4 Earnings call transcript

Theravance Biopharma (TBPH)-12 Nov 24-2024 Q3 Earnings call transcript

Theravance Biopharma (TBPH)-5 Aug 24-2024 Q2 Earnings call transcript

Theravance Biopharma (TBPH)-13 May 24-2024 Q1 Earnings call transcript

Theravance Biopharma (TBPH)-26 Feb 24-2023 Q4 Earnings call transcript

Theravance Biopharma (TBPH)-7 Nov 23-2023 Q3 Earnings call transcript

Theravance Biopharma (TBPH)-7 Aug 23-2023 Q2 Earnings call transcript

Theravance Biopharma (TBPH)-8 May 23-2023 Q1 Earnings call transcript

Theravance Biopharma (TBPH)-27 Feb 23-2022 Q4 Earnings call transcript

Theravance Biopharma (TBPH)-8 Nov 22-2022 Q3 Earnings call transcript

Theravance Biopharma (TBPH)-7 Aug 22-2022 Q2 Earnings call transcript

Theravance Biopharma (TBPH)-7 May 22-2022 Q1 Earnings call transcript

Theravance Biopharma (TBPH)-24 Feb 22-2021 Q4 Earnings call transcript

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Theravance Biopharma (TBPH)-1 Aug 18-2018 Q2 Earnings call transcript

Theravance Biopharma (TBPH)-8 May 18-2018 Q1 Earnings call transcript

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